Feasibility of a Virtual Reality Based Sensorimotor Training Intervention for Patients with Chronic Traumatic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Feasibility - Recruitment time (weeks)
研究概览
简要总结
The goal of this clinical trial is to learn if a virtual reality (VR) intervention for people with chronic neck pain is feasible. The main questions it aims to answer are:
Is it possible to perform a future full-scale randomized controlled trial (RCT) with a remotely supervised VR-based intervention for people with chronic neck pain?
How do people with neck pain experience using VR in a home-based training intervention?
Researchers will investigate if aspects of a full-scale RCT is feasible. This includes how well the recruitment of participants worked, retention during the intervention, compliance to training program, adverse events, and experience using the VR during training. The study will also investigate initial indication of benefit of the VR intervention, such as effects on pain and function.
Participants will be randomly assigned to either a VR neck training group or an endurance training group. Both groups will perform a training program for 8 weeks with weekly follow ups with their physiotherapist via online meetings.
详细描述
Title: Feasibility of a Virtual Reality-Based Sensorimotor Training Intervention for Patients with Chronic Traumatic Neck Pain
Background: Neck pain is very common, leading to reduced function and quality of life, and is costly for healthcare and society due to sick leave and productivity loss. The cause of neck pain is often unclear, with no visible structural damage. Persistent neck pain (lasting more than 3 months) and recurrent episodes are complex and not fully understood. Research suggests impaired sensorimotor control as a contributing factor.
Sensorimotor control involves neck movement control, awareness of head position, quick reaction to stimuli, and good neck mobility. These functions are crucial for daily activities (e.g., moving our body, riding a bike, driving a car), and maintaining body stability. Research has shown that these functions often are impaired in people with neck pain. Training these functions can reduce pain and improve function.
Virtual Reality (VR) technology, especially VR headsets, allows objective assessment of neck sensorimotor functions, crucial for personalized training to reduce pain and improve function. VR can measure movement velocity and reaction time, previously only possible with advanced lab equipment. VR can be used in clinics and at home, showing high accuracy in assessing neck functions. It may also make training enjoyable, potentially improving adherence.
Aim: This study aims to assess the feasibility of a future large-scale randomized controlled trial (RCT) using a VR-based training program for chronic neck pain patients. It will explore various feasibility aspects to plan a well-conducted RCT and examine participants' experiences with VR. Aspects include participant recruitment, adherence to intervention, study protocol feasibility, experience of VR based intervention, and initial effects on pain and function. Data will also help calculate the required sample size for a future RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand verbal and written Swedish
- •Persistent neck pain (>3 months)
- •Neck pain onset (or acute worsening) in relation to trauma to the head or neck
- •Neck disability index 20-60% or Numeric Rating Scale neck pain ≥ 3/10
- •Impaired sensorimotor function of the neck (at least one of the sensorimotor tests must be impaired, i.e. below the norm values for the test in question). The following cut-off values are used:
- •Joint position sense test: > 4.5° absolute error in any of the four directions right rotation, left rotation, extension or flexion.
- •Movement sense test: >28 seconds to complete the zigzag pattern, or <2,5 norm value (i.e., accuracy in percentage divided by time in seconds).
- •Maximum velocity from the cervical reaction acuity test: < 100°/s. Range of motion in right rotation, left rotation, extension and flexion (added together): < 300°.
排除标准
- •Cervical radiculopathy
- •Neck surgery
- •Fracture of the neck
- •Neurological disease
- •Vestibular disease
- •Rheumatic disease
- •Concussion where the person lost consciousness
- •Uncorrected visual impairment
- •Previous experience of severe symptoms (nausea/dizziness) when using VR headsets
结局指标
主要结局
Feasibility - Recruitment time (weeks)
时间窗: From enrollment to end of treatment (at 8 weeks)
Time taken to recruit 20 participants. This will be measured in number of weeks.
Feasibility - Recruitment method
时间窗: From enrollment to end of treatment (at 8 weeks)
Which recruitment channels were effective to find participants? (physiotherapy clinics, social media channels, newspaper advertisement, other). This will be measured by asking the participants.
Feasibility - Adherence
时间窗: Start of intervention to end of intervention at 8 weeks.
Adherence rate to interventions. For the VR training group this is evaluated from the VR online portal training log. For the endurance training group this is evaluated from training diaries. This will be measured by number of completed training sessions and presented as percentage of prescribed dosage. A minimum of 70 % completed training sessions is considered acceptable. Adherence feasibility criteria: ≥ 70% Proceed, 60-69% Proceed with changes, \<60% Do not proceed
Feasibility - Completion rate (drop out)
时间窗: Start of intervention to end of intervention at 8 weeks.
Number of participants completing the intervention. Intervention completion rate feasibility criteria: ≥ 85% proceed, 70-85% proceed with changes, \<70% do not proceed.
Feasibility - Outcome measure completion rate
时间窗: At 8 weeks
Obtained outcome measures from participants completing the intervention. Outcome measure completion rate criteria: ≥ 85% Proceed, 70-85% Proceed with changes, \<70% Do not proceed
Feasibility - Adverse events
时间窗: From start of intervention to 8 weeks
Number of adverse events and what character. Treating physiotherapists will record any adverse events during the intervention period.
Feasibility - Numeric Rating Scale (NRS) Simulator sickness intensity
时间窗: Baseline and at end of intervention (at 8 weeks).
Sickness intensity measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their sickness intensity right after completion of the test protocol, from no sickness (0) to worst imaginable sickness (10).
Feasibility - Participants experience using VR in neck training - Qualitative part
时间窗: After completion of the 8 weeks VR-intervention, approximately within 2 weeks after completion.
Participants experience using VR in the 8-week intervention. This information will be obtained from semi-structured interviews, e.g., questions about usability, digitally delivered intervention, video consultations with physiotherapists, information and support, pros and cons of intervention.
次要结局
- Cervical joint position sense (JPS) test (performed in the VR headset)(Baseline and at end of intervention (at 8 weeks))
- Cervical reaction acuity (CRA) test - Reaction time milliseconds (performed in the VR headset)(Baseline and at end of intervention (at 8 weeks))
- Cervical reaction acuity (CRA) test - Maximum velocity. (performed in the VR headset)(Baseline and at end of intervention (at 8 weeks))
- Cervical reaction acuity (CRA) test - Time to complete the task. (performed in the VR headset)(Baseline and at end of intervention (at 8 weeks))
- Cervical movement sense test (performed in the VR headset)(Baseline and at end of intervention (at 8 weeks))
- Cervical range of motion test (performed in the VR headset)(Baseline and at end of intervention (at 8 weeks))
- Postural sway in quiet stance (performed with the VR headset)(Baseline and at end of intervention (at 8 weeks))
- Cervical flexion endurance test(Baseline and at end of intervention (at 8 weeks))
- Neck Disability Index (NDI)(Baseline and at end of intervention (at 8 weeks))
- Numeric Rating Scale (NRS) neck pain(Baseline and at end of intervention (at 8 weeks))
- Numeric Rating Scale (NRS) dizziness(Baseline and at end of intervention (at 8 weeks))
- Numeric Rating Scale (NRS) headache(Baseline and at end of intervention (at 8 weeks))
- EQ-5D-5L(Baseline and at end of intervention (at 8 weeks))
- Tampa scale of kinesiophobia -short version 11 item (TSK-11)(Baseline and at end of intervention (at 8 weeks))
- Global perceived effect (GPE)(At end of intervention (at 8 weeks))
- Feasibility - Physiotherapists experience of the VR intervention- Measured with a questionnaire.(After all participants have completed post intervention assessments at the end of the intervention (at 8 weeks))